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FDA to revise Compliance Policy Guide on veterinary compounding

Posted Oct. 1, 2004

The Food and Drug Administration has announced its intention to draft and publish for public comment a revised Compliance Policy Guide on veterinary pharmaceutical compounding. The FDA anticipates that the draft CPG will be available for comment this fall.

The current CPG, published in July 2003, describes the FDA's position on what types of veterinary compounding might be subject to enforcement action.

The FDA has received numerous letters from veterinarians, pet owners, compounding pharmacists, and associations—including the AVMA—expressing concern that the CPG lacks sufficient clarity on the circumstances in which veterinary compounding, particularly from bulk drugs, would be permitted.

Many of the letters also disagreed with the current policy, stating that it was not within the FDA's legal authority, and complained about the lack of prior public comment.

The AVMA requested the policy be amended to grant veterinarians the discretion to compound bulk pharmaceutical ingredients to produce a medically necessary product that is otherwise unavailable for a specific nonfood animal patient.

After meeting with several groups and considering the comments in the letters it has received, the FDA concluded that issuing a revised CPG is appropriate.

When it is available, the draft CPG will be posted on the FDA's Center for Veterinary Medicine Web site, www.fda.gov/cvm/default.html, and a notice of availability will be published in the Federal Register.

Questions on veterinary pharmaceutical compounding or the existing CPG may be directed to Gloria Dunnavan, Division of Compliance director, (301) 827-1168, or gdunnavan@cvm.fda.gov.